UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Acronym	A randomized study of furosemide or mannitol in short hydration chemotherapy
Scientific Title	A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Scientific Title:Acronym	A randomized study of furosemide or mannitol in short hydration chemotherapy
Region	Japan

Condition
Condition	Chemotherapy naive thoracic malignancy
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of furosemide compared with mannitol in cisplatin-based chemotherapy(>=60mg/m2) using short hydration in chemotherapy naive patients with thoracic malignancy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The proportion of patients experienced >=Grade1 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the upper limit of the normal range (ULN) for serum creatinine at each institute)
Key secondary outcomes	1)The proportion of patients experienced >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute) 2) The proportion of patients experienced >=Grade1 and >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the pretreatment baseline creatinine score in each patient) 3) The proportion of patients experienced >=Grade1 and >=Grade2 renal dysfunction after the completion of forth cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute and on the pretreatment baseline creatinine score in each patient) 4)The proportion of patients with phlebitis and severity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	20% mannitol 300ml, in 30min
Interventions/Control_2	furosemide 20mg, intravenous infusion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Thoracic malignancy 2)ECOG PS 0-1 3)Creatinine clearance rate of >=60mL/min 4)Previously untreated with cisplatin-based chemotherapy
Key exclusion criteria	With Superior Vena Cava syndrome
Target sample size	115

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Yamamoto
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama-city
TEL	0734410619
Email	erikom@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Eriko Middle name Last name Murakami
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama-city
TEL	0734410619
Homepage URL
Email	erikom@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wakayama Medical University Institutional Review Board
Address	811-1, Kimiidera, Wakayama-city
Tel	073-447-2300
Email	wa-rinri@wakayama-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	和歌山県立医科大学附属病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Related information
URL releasing protocol	https://bmjopen.bmj.com/content/9/12/e029057
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	115
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 02 Month 16 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 05 Month 07 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 26 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036439